Risk Based Research Management

1. Risk Based Research Management Sarah Corcoran RGN, DPSN, BA Hons Head of Risk Management at Central Manchester and Manchester Children’s NHS Trust

2. STANDARD Healthcare organisations which either lead or participate in research activities adhere to, and apply consistently, the principles and requirements of the Research Governance Framework. OVERVIEW Research is essential to the successful promotion and protection of health and well-being and to modern and effective health and social care services. At the same time, research can involve an element of risk, both in terms of return on investment and sometimes for the safety and well-being of the research participants. Proper governance of research is therefore essential to ensure that the public can have confidence in, and benefit from, quality research in health and social care. The public has a right to expect high scientific, ethical, and financial standards, transparent decision-making processes, clear allocation of responsibilities and robust monitoring arrangements.

3. Risk - definitions • hazard: a source of danger; a possibility of incurring loss or misfortune; "drinking alcohol is a health hazard" • a venture undertaken without regard to possible loss or injury; "he saw the rewards but not the risks of crime"; "there was a danger he would do the wrong thing" • expose to a chance of loss or damage; "We risked losing a lot of money in this venture"; "Why risk your life?" • the probability of becoming infected given that exposure to an infectious agent has occurred • gamble: take a risk in the hope of a favorable outcome; "When you buy these stocks you are gambling" www.cogsci.princeton.edu/cgi-bin/webwn

4. The uncertainty of an event occurring that could have an impact on the achievement of objectives. Risk is measured in terms of consequences and likelihood.www.mcgill.ca/internalaudit/tools/definitions/

5. Risk is an album by the metal band Megadeth released in 1999. en.wikipedia.org/wiki/Risk_(album)

6. “ , the rational model of the traditional research methods textbook, which presents the research process as an idealized, neat series of logically directed steps, does not of course provide a description of the way in which research is actually conducted.

7. Cont…. Rather like the managerial process, which until recently was idealized by textbooks an a logical orderly one of planning [………] , there is now widespread recognition of the view that ‘idiosyncrasies of the person and circumstance are at the heart, not the periphery of scientific enterprise’ (Bell and Newby, 1977) in, Gill,J and Johnson,P. Research Methods for Managers . Paul Chapman Publishing 1997

8. Risk Assessment • The overall process of risk analysis and evaluation.

9. Risk Acceptance • An informed decision to accept the consequences and likelihood of a particular risk.

10. Risk Control • That part of risk management which involves the implementation of policies, standards, procedures, physical changes etc to eliminate or minimise risks.

11. May be identified by risk assessment Identify Broad Area May be identified by risk assessment Select Topic Risk assessing the approach may alert Team to potential problems in the future. Decide Approach Circulation and risk assessment by team may alert to problems with the plan. Formulate Plan Collect Information Risk assessment of data collection and analysis processes could prevent methodology errors. Do the findings pose different risks or have they identified risks? Analyse Data Present Findings

12. Benefits for R&D RA’s can support R&D staff in their every day work and protect projects from process errors RA’s can ensure R&D recommendations are robustly examined and new risks introduced are properly evaluated. RA’s can lead to decisions about which R&D projects to undertake and directly influence decisions on funding etc

13. Risk Register Risk management processAS/NZS 4360:1999 - Risk management Establish Context Identify Risks Analyse Risks Monitor and review Communicate and Consult ASSESS RISKS Evaluate and Rank Risks Treat Risks

14. The Risk Register

15. Management of Risk Registers

16. For Example…… Each of these groups asks questions of one another – an Assurance Framework is developed in order to maintain the ongoing process and ensure responsibilities are correctly defined and executed.

17. Risk Assessment • facilitates communication between decision-makers, technical experts, and other interested parties, by providing explicit data which is amenable to review and describes shortfalls, such as the nature and extent of uncertainties attached to the data. • identifies the role and impact of policy considerations (eg. social, political or economic) in the evaluation of information which is essentially scientific in nature;

18. provides a framework for examining explicitly the potential adverse consequences of alternative risk management policies or actions; • helps to identify research needs and research priorities; • assists the UK in its efforts to foster the adoption of a goal-setting approach to legislation during the negotiation of international or European Union (EU) legislation, agreements or standards. • http://www.hse.gov.uk/aboutus/meetings/ilgra/minrpt1c.htm

19. But……many of you have been doing this for a long time…….

20. You've carefully thought out all the angles. • You've done it a thousand times. • It comes naturally to you. • You know what you're doing, its what you've been trained to do your whole life. • Nothing could possibly go wrong, right ?

21. Wrong….!

24. Stages of Development of Organisational Accident : James Reason Contributory Factors Influencing Clinical Practice Organisational & Corporate Culture Task Defence Barriers Error Producing Conditions Violation Producing Conditions Errors Violations Accident /Incident Management Decisions and Organisational Processes

26. Risk Grading Matrix

27. “Here is Edward Bear,coming downstairs now, bump, bump, bump, on the back of his head, behind Christopher Robin. It is, as far as he knows, the only way of coming downstairs, but sometimes he feels that there really is another way, if only he could stop bumping for a moment and think of it” A.A. Milne 1926 Illustration E.H.Shepard 192614

28. Any Questions? • Sarah Corcoran, Head of Risk Management • sarah.corcoran@cmmc.nhs.uk • 0161 276 6179